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Genetic Study of Families With High Frequency of Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT02795013
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
HudsonAlpha Institute for Biotechnology
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL in more than one child, or parent and child). Because affected individuals in familial HL are genetically related, the existence of such families has long been considered as evidence in support of a genetic basis of HL susceptibility. However, it is largely unknown which genetic variations are responsible for recurring HL in families. Because the effects of genetic variants are likely to be strong in familial HL, identification of such variations will potentially reveal biological pathways critical to the pathogenesis of HL.

PRIMARY OBJECTIVE:

  • To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases (affected as well as non-affected family members) to identify potential disease-causing germline genetic variations.

SECONDARY OBJECTIVE:

  • To describe demographic and clinical features of the affected families.

Condition or disease
Hodgkin Lymphoma

Detailed Description:

This study entails a clinical interview and submission of a peripheral blood or saliva sample for non-tumor DNA. Participants diagnosed with HL at outside institutions will be requested to sign a release form to allow the outside institution to send their pathology report confirming their HL diagnosis. If available, previously banked tumor tissue samples will be utilized to assess genetic alterations related to HL. Detailed history will be obtained (e.g., demographics, environmental exposures, cancer risk factors, and family pedigree) to facilitate the analysis of phenotype-genotype correlations, taking into account potential confounding factors.

Investigators will examine the germline and possibly the tumor DNA of each individual participant and use the data from all participants to determine if a gene change is related to HL.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic Study of Families With High Frequency of Hodgkin Lymphoma
Actual Study Start Date : August 17, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Participants with Hodgkin Lymphoma
Those with a confirmed diagnosis of Hodgkin Lymphoma (HL) and family members who consent and enroll in this study.
Family Members without Hodgkin Lymphoma
Those unaffected by HL will serve as a control group to compare with those with HL.



Primary Outcome Measures :
  1. Germline genetic variations [ Time Frame: Once, within 1 month of enrollment ]
    Whole exome sequencing of affected and unaffected individuals in these families will be performed. Genetic variants potentially related to HL will be identified on the basis of its co-segregation with HL disease status (e.g., unique variants in individuals affected by HL would be considered as risk variants). Family members without HL (regardless of any other history of malignancy) will be considered as control and be compared against members with HL.


Biospecimen Retention:   Samples With DNA
Saliva, minimal blood, or tumor will be retained for whole exome sequencing.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed diagnosis of Hodgkin Lymphoma (HL), and family members of the patient, either affected or unaffected by a malignancy.
Criteria

Inclusion Criteria:

  • Patient with HL diagnosed ≤ 21 years of age with a first-degree relative also diagnosed with HL.
  • Family members of the patient, either affected or unaffected by a malignancy who agree to participate in the study.
  • Research participant or legal guardian, as appropriate, must provide informed consent for this protocol.

Exclusion Criteria:

  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795013


Contacts
Contact: Jamie Flerlage, MD 866-278-5835 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jamie Flerlage, MD    866-278-5835    referralinfo@stjude.org   
Principal Investigator: Jamie Flerlage, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
HudsonAlpha Institute for Biotechnology
Investigators
Principal Investigator: Jamie Flerlage, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02795013     History of Changes
Other Study ID Numbers: FAMHL
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Genetic studies
Pediatric

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases